Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT) (CBPT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03335657|
Recruitment Status : Active, not recruiting
First Posted : November 8, 2017
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lower Extremity Injury||Other: CBPT Other: Education Treatment||Not Applicable|
Following extremity injury, referral (and direct access) to physical therapy (PT) is considered standard of care. And, while PT strategies are commonly impairment focused, clinicians across multiple subspecialties of physical therapy recognize the importance of addressing pain and pain-related psychosocial factors as strong predictors of chronic pain as well as long-term physical and psychological disability.
Cognitive-behavioral therapy (CBT) interventions have documented positive influence on psychosocial factors in patients with chronic pain. CBT-based self-management programs have also demonstrated improvement in patient outcomes and the adoption of a physically active lifestyle, as well as improvement in fear-avoidance beliefs and self-efficacy, in various populations with chronic conditions. These evidence-based CBT and self-management strategies provide the basis for the study intervention.
The proposed project will conduct a multi-center, randomized controlled trial to determine the efficacy of the CBPT program in patients at-risk for poor outcomes following traumatic lower-extremity injury. Central hypothesis is that delivery of CBPT by physical therapists over the telephone will improve outcomes, through reductions in pain catastrophizing and fear of movement and improvement in pain self-efficacy. The investigators propose a large, rigorous evaluation of the CBPT program in patients with lower extremity trauma with the goal of engaging civilians and service members in their own care and improving pain and functional outcomes.
Specific Aim 1 To determine the efficacy of the CBPT program for improving outcomes in service members and civilians at-risk for poor outcomes following traumatic lower-extremity injury. Primary outcome is physical function measured through a patient-reported questionnaire. Secondary outcomes include physical performance tests, pain and general health. Tertiary outcome is return to work/duty.
Specific Aim 2 To determine whether changes in the intermediary outcomes of pain catastrophizing, fear of movement, and self-efficacy at 6 months are associated with improvement in outcomes 12 months after hospital discharge.
Specific Aim 3 To determine whether subgroups of patients are more likely to benefit from the CBPT program.
Specific Aim 4 To examine the value of CBPT relative to Education using Markov decision-analysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||633 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)|
|Actual Study Start Date :||July 18, 2018|
|Estimated Primary Completion Date :||July 18, 2021|
|Estimated Study Completion Date :||July 18, 2021|
Experimental: CBPT Treatment
The CBPT intervention delivers a patient-oriented cognitive-behavioral self-management program to improve physical function and reduce pain, through reductions in pain catastrophizing and fear of movement and increases in self-efficacy. The program consists of six weekly telephone sessions with a trained physical therapist. Sessions cover an introduction and rationale for treatment in addition to techniques such as deep breathing, graded activity plan and goal-setting, distraction techniques, automatic thoughts, coping self-statements, being present-minded, and relapse prevention and symptom management plans. At the end of the 6th week, patients will build individualized recovery plans with selected strategies and details on frequency of practice.
The CBPT program focuses on a patient-oriented cognitive-behavioral self-management approach to improve physical function and reduce pain, through reductions in pain catastrophizing and fear of movement and increases in self-efficacy.
Placebo Comparator: Education Treatment
The education program provides a postoperative recovery and is based on education that would typically be provided by a treating physician or a physical therapist in an outpatient setting. The education program is matched to the CBPT treatment in terms of session frequency and contact with the study therapist. The therapist will call weekly to check in with the patient and encourage him/her to read the manual. Manuals contain educational information on injury patterns and symptoms, stress and recovery, benefits of physical therapy, and importance of daily exercise, and ways to promote healing. Education on sleep hygiene, energy management, healthy eating, and preventing future injury are also provided.
Other: Education Treatment
Participants receiving the education control arm are receiving a placebo intervention to control for the attention of the interventionist. They will receive standardized educational material addressing recovery from orthopaedic trauma.
- Physical Function- self-reported capability to carry out activities [ Time Frame: 12 months ]Physical Function measured through Patient Reported Outcome Measurement Information System (PROMIS)/ Physical Function (short form) domain to assess one's ability to carry out activities that require a combination of skills, often within a social context. This instrument has five response options ranging in value from one to five for each question. The total raw score is the sum of values of the response for each question The highest possible raw score is 40 which represents the worse outcome. The lowest possible score is 8 and it represents the better outcome.
- Pain [ Time Frame: 12 months ]Measured through Patient Reported Outcome Measurement Information System (PROMIS)/ Pain Intensity (short form) Domain at 12-months following hospital discharge. This tool has five response options ranging in value from one to five for each question. The total raw score is the sum of values of the response for each question The highest possible raw score is 15 which represents the worse outcome. The lowest possible score is 3 and it represents the better outcome.
- General Health [ Time Frame: 12 months ]General Health measured through Patient Reported Outcome Measurement Information System (PROMIS)/ General Health Domain at 12-months following hospital discharge.This instrument has five response options ranging in value from one to five for each question. The total raw score is the sum of values of the response for each question The highest possible raw score is 50 which represents the better outcome. The lowest possible score is 10 and it represents the worse outcome.
- Physical Function- Balance and Agility [ Time Frame: 12 months ]Balance and Agility measured through the Four Square Step test. Each individual will have time scores based on performance. Higher scores represent worse outcomes.
- Physical Function- Mobility and Power [ Time Frame: 12 months ]Mobility and Power measured through the Timed Stair Ascent test. Each individual will have time scores based on performance. Higher scores represent worse outcomes.
- Physical Function-Leg Strength, Endurance, and Mobility [ Time Frame: 12 months ]Leg Strength, Endurance, and Mobility measured through the Sit to Stand Five Times
- Physical Function- Gait Speed [ Time Frame: 12 months ]Gait Speed measured through 10-Meter Walk test. Each individual will have time scores
- Return to work/duty [ Time Frame: 6 months ]Measured through the rate of return to work/duty 6 months post discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335657
|United States, Florida|
|Florida Orthopaedic Institute|
|Tampa, Florida, United States, 33606|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Maryland|
|University of Maryland, R Adams Cowley Shock Trauma Center|
|Baltimore, Maryland, United States, 20742|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28203|
|United States, Tennessee|
|Vanderbilt Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|The University of Texas Health Science Center at Houston Medical School|
|Houston, Texas, United States, 78229|
|San Antonio Military Medical Center|
|San Antonio, Texas, United States, 78434|
|Principal Investigator:||Kristin Swygert, PhD||Vanderbilt University Medical Center|
|Study Director:||Katherine Frey, PhD||Johns Hopkins University|